Market Overview

Can-Fite Reports Third Quarter 2017 Financial Results & Provides Clinical Update

  • Namodenoson:
    • Commences enrollment in Phase II NAFLD/NASH trial
    • Completes enrollment in Phase II liver cancer trial
    • Receives milestones payment from Korean distributor
  • Piclidenoson:
    • Commences enrollment in Phase III rheumatoid arthritis trial
      as a replacement for standard of care MTX

BioPharma Ltd
. (NYSE:CANF) (TASE:CFBI), a biotechnology company
advancing a pipeline of proprietary small molecule drugs that address
cancer, liver and inflammatory diseases, today reported financial
results for the nine months ended September 30, 2017 and provided
clinical and corporate updates.

Clinical Development Program and Corporate Highlights Include:

Namodenoson (CF102): Advances Phase II Trials
and Receives Milestone Payment

  • First Patient Enrolled in Phase II Trial for Treatment of NAFLD/NASH

Patient enrollment has commenced in Can-Fite's Phase II trial of
Namodenoson in the treatment of non-alcoholic fatty liver disease
(NAFLD) and non-alcoholic steatohepatitis (NASH). The 12-week trial is
enrolling approximately 60 patients and is estimated to cost less than
$1 million. There is currently no U.S. FDA approved drug for the
indication of NASH, which is an addressable pharmaceutical market
estimated to reach $35-40 billion by 2025.

  • Milestone Payment Received for Distribution of Namodenoson in Korea
    for the Treatment of Liver Cancer

During the third quarter of 2017, Can-Fite received a milestone payment
of $500,000 from Chong Kun Dang Pharmaceuticals (CKD), which licensed
the exclusive right to distribute Namodenoson for the treatment of liver
cancer in Korea upon receipt of regulatory approvals. The payment is
part of a deal worth up to $3,000,000 in upfront and milestone payments
plus 23% royalties.

  • Patient Enrollment Completed in Phase II Liver Cancer Trial of

Can-Fite completed enrollment during the third quarter of 2017 and
randomized all 78 patients in its global Phase II study of Namodenoson
in the treatment of hepatocellular carcinoma (HCC), the most common form
of liver cancer. Patients with advanced HCC, Child Pugh B, were enrolled
in the U.S., Europe and Israel. The primary endpoint of the Phase II
study is overall survival. Can-Fite is following the survival data
closely and plans to perform the survival analysis at the earliest
possible opportunity. The HCC market is expected to generate $1.4
billion in sales in 2019.

  • Data Presented on Namodenoson at NASH Summit Europe and The Liver

Dr. Pnina Fishman, Can-Fite's CEO, joined global thought-leaders in the
treatment of NASH at the NASH Summit Europe in October, in Frankfurt,
Germany, where she delivered a presentation titled, "The Anti-Fibrogenic
and Liver Protective Effects of Namodenoson (CF102): From Preclinical to
Human Studies."

Can-Fite also presented two scientific posters at the American
Association for the Study of Liver Diseases (AASLD) annual conference,
The Liver Meeting® in Washington, D.C. in October. The posters were
titled "Namodenoson (CF102) Prevents Liver Fibrosis in the CCL4 Model"
and "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson
(CF102) in a Non-Alcoholic Steatohepatitis model."

Piclidenoson (CF101): Commences Patient
Enrollment and Dosing in ACRobat Phase III Trial in Rheumatoid Arthritis

Patient enrollment and dosing has commenced in Can-Fite's Phase III
ACRobat trial that is evaluating Piclidenoson as a first line treatment
and replacement for the current standard of care, Methotrexate (MTX),
the most widely used drug for rheumatoid arthritis. The trial is
enrolling approximately 500 patients in Europe, Canada and Israel. The
estimated cost of the entire 24-week Phase III study is approximately $5
million. An estimated 90% of rheumatoid arthritis patients receive MTX
at some point in their disease. However, studies show that up to 50% of
patients stop taking MTX due to reasons including drug intolerance,
minor and major side effects, and lack of efficacy, creating a
significant need for a new, safe and effective treatment option in the
rheumatoid arthritis treatment market which is forecast to reach $34.6
billion by 2020.

Can-Fite is also advancing Piclidenoson towards a Phase III trial in the
treatment of psoriasis which is expected to commence in 2018. The
upcoming trial will investigate the efficacy and safety of Piclidenoson
compared to placebo as its primary endpoint and as compared to
apremilast (Otezla®) as its secondary endpoint in approximately 400
patients with moderate-to-severe plaque psoriasis. The psoriasis market
is forecast to be $8.9 billion in 2018 and Otezla® sales are estimated
to be $2.35 billion by 2020.

Expands Intellectual Property

Can-Fite was issued a new patent from the Korean Intellectual Property
Office for Piclidenoson titled, "Pharmaceutical Composition Comprising
A3 Adenosine Receptor Agonist (IB-MECA/CF-101) For Treatment of

A new patent application was filed by Can-Fite to protect the use of its
drugs and other ligands which target the A3 adenosine receptor (A3AR) in
the treatment of cytokine release syndrome (CRS), a potentially
life-threatening complication of CAR-T cell therapy. CAR-T is viewed by
the medical community as a very promising cancer immunotherapy, however,
CRS, which is caused by an overactive immune response to the treatment,
has been identified as a potentially severe and life-threatening side
effect of CAR-T. Can Fite's platform technology selectively targets
A3AR, which plays a central role in mediating the mechanism of
inflammation in CRS, and as such, Can-Fite believes that A3AR targeting
may serve as an important treatment option for patients in reducing the
risk of CRS without limiting the utility of the underlying cancer

Can-Fite's Former Subsidiary OphthaliX
Successfully Completes Merger with Wize Pharma

Can-Fite's former majority-owned subsidiary, OphthaliX Inc. (since
renamed Wize Pharma, Inc.) recently completed a merger with Wize Pharma
Ltd. As a result of the merger, Can-Fite's ownership of OphthaliX,
immediately post-merger, became approximately 8% of the outstanding
shares of common stock. In addition, immediately prior to the merger,
OphthaliX sold on an "as is" basis to Can-Fite all the ordinary shares
of Eyefite Ltd., a former wholly owned subsidiary of OphthaliX, in
exchange for the irrevocable cancellation and waiver of all indebtedness
owed by OphthaliX and Eyefite to Can-Fite, including approximately $5
million of deferred payments and, as part of the purchase of Eyefite,
Can-Fite also assumed certain accrued milestone payments in the amount
of $175,000 under a license agreement previously entered into with the
U.S. National Institutes of Health (NIH). In addition, as a result of
the merger, an exclusive license of Piclidenoson (CF101) for the
treatment of ophthalmic diseases previously granted by Can-Fite to
OphthaliX and a related services agreement was terminated.

"We are pleased to be on target with commencing patient enrollment in
our Phase III rheumatoid arthritis and Phase II in NAFLD/NASH studies.
Namodenoson is gaining increasing recognition in the medical community,
as evidenced by our recent scientific presentations, for its liver
protective properties in both NASH and liver cancer. In 2018, we look
forward to initiating our Phase III study of Piclidenoson in psoriasis,
as well as potentially announcing top line data on our Phase II liver
cancer study of Namodenoson," Dr. Fishman stated.

Financial Results

Revenues for the nine months ended September 30, 2017 were NIS 2.61
million (U.S. $0.74 million) compared to NIS 0.64 million (U.S. $0.18
million) in the first nine months of 2016. The increase in revenue was
mainly due to payment received of NIS 1.8 million (U.S. $0.5 million) in
August 2017 under the distribution agreement with CKD.

Research and development expenses for the nine months ended September
30, 2017 were NIS 12.7 million (U.S. $3.6 million) compared with NIS
15.45 million (U.S. $4.38 million) for the same period in 2016. Research
and development expenses for the nine months ended September 30, 2017
comprised primarily of expenses associated with the Phase II study for
Namodenoson as well as expenses for ongoing studies of Piclidenoson. The
decrease is primarily due to a reduction in preclinical studies of CF602
conducted during the nine months ended September 30, 2017.

General and administrative expenses were NIS 7.48 million (U.S. $2.12
million) for the nine months ended September 30, 2017, compared to NIS
7.88 million (U.S. $2.23 million) for the same period in 2016. The
decrease in general and administrative expenses was mainly due to a
decrease in investor relations expenses.

Financial income, net for the nine months ended September 30, 2017
aggregated NIS 3.91 million (U.S. $1.11 million) compared to financial
income, net of NIS 3.12 million (U.S. $0.88 million) for the same period
in 2016. The increase in financial income, net in the nine months ended
September 30, 2017 was mainly from a larger decrease in the fair value
of warrants that are accounted for as financial liability as compared to
the same period in 2016, offset by exchange rate differences as compared
to the same period in 2016 and from issuance expenses.

Can-Fite's net loss for the nine months ended September 30, 2017 was NIS
13.75 million (U.S. $3.90 million) compared with a net loss of NIS 19.56
million (U.S. $5.54 million) for the same period in 2016. The decrease
in net loss for the nine months ended September 30, 2017 was primarily
attributable to a decrease in research and development expenses.

As of September 30, 2017, Can-Fite had cash and cash equivalents of NIS
18.02 million (U.S. $5.11 million) as compared to NIS 31.2 million (U.S.
$8.84 million) at December 31, 2016. The decrease in cash during the
nine months ended September 30, 2017 is due to use of cash to fund
operating expenses.

For the convenience of the reader, the reported NIS amounts have been
translated into U.S. dollars, at the representative rate of exchange on
September 30, 2017 (U.S. $1 = NIS 3.529).

The Company's consolidated financial results for the nine months ended
September 30, 2017 are presented in accordance with International
Financial Reporting Standards.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE:CFBI) is an advanced
clinical stage drug development Company with a platform technology that
is designed to address multi-billion dollar markets in the treatment of
cancer, inflammatory disease and sexual dysfunction. The Company's lead
drug candidate, Piclidenoson, is currently in a Phase III trial for
rheumatoid arthritis and is expected to enter a Phase III trial for
psoriasis in early 2018. Can-Fite's liver cancer drug, Namodenoson, is
in Phase II trials for hepatocellular carcinoma (HCC), the most common
form of liver cancer, and for the treatment of non-alcoholic
steatohepatitis (NASH). Namodenoson has been granted Orphan Drug
Designation in the U.S. and Europe and Fast Track Designation as a
second line treatment for HCC by the U.S. Food and Drug Administration.
Namodenoson has also shown proof of concept to potentially treat other
cancers including colon, prostate, and melanoma. CF602, the Company's
third drug candidate, has shown efficacy in the treatment of erectile
dysfunction in preclinical studies and the Company is investigating
additional compounds, targeting A3AR, for the treatment of sexual
dysfunction. These drugs have an excellent safety profile with
experience in over 1,000 patients in clinical studies to date. For more
information please visit:

Forward-Looking Statements

This press release may contain forward-looking statements, about
Can-Fite's expectations, beliefs or intentions regarding, among other
things, market risks and uncertainties, its product development efforts,
business, financial condition, results of operations, strategies or
prospects. In addition, from time to time, Can-Fite or its
representatives have made or may make forward-looking statements, orally
or in writing. Forward-looking statements can be identified by the use
of forward-looking words such as "believe," "expect," "intend," "plan,"
"may," "should" or "anticipate" or their negatives or other variations
of these words or other comparable words or by the fact that these
statements do not relate strictly to historical or current matters.
These forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or with
the approval of one of Can-Fite's authorized executive officers.
Forward-looking statements relate to anticipated or expected events,
activities, trends or results as of the date they are made. Because
forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that
could cause Can-Fite's actual results to differ materially from any
future results expressed or implied by the forward-looking statements.
Many factors could cause Can-Fite's actual activities or results to
differ materially from the activities and results anticipated in such
forward-looking statements. Factors that could cause our actual results
to differ materially from those expressed or implied in such
forward-looking statements include, but are not limited to: the
initiation, timing, progress and results of our preclinical studies,
clinical trials and other product candidate development efforts; our
ability to advance our product candidates into clinical trials or to
successfully complete our preclinical studies or clinical trials; our
receipt of regulatory approvals for our product candidates, and the
timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain corporate
collaborations; the implementation of our business model and strategic
plans for our business and product candidates; the scope of protection
we are able to establish and maintain for intellectual property rights
covering our product candidates and our ability to operate our business
without infringing the intellectual property rights of others; estimates
of our expenses, future revenues, capital requirements and our needs for
additional financing; competitive companies, technologies and our
industry; statements as to the impact of the political and security
situation in Israel on our business; and risks and other risk factors
detailed in Can-Fite's filings with the SEC and in its periodic filings
with the TASE. In addition, Can-Fite operates in an industry sector
where securities values are highly volatile and may be influenced by
economic and other factors beyond its control. Can-Fite does not
undertake any obligation to publicly update these forward-looking
statements, whether as a result of new information, future events or



In thousands (except for share and per share data)



September 30,     September 30,     December 31,
2017 2017 2016
Unaudited Audited
Cash and cash equivalents 5,106 18,018
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